The disclosure relates to apparatus, systems and methods for an intra-operative imaging system for visualizing microscopic disease.
Successful treatment of early stage cancer, such as prostate and breast cancer, depends on completely resecting all disease, both gross and microscopic, while sparing healthy tissue. Unfortunately, because microscopic disease is challenging to visualize intraoperatively, yet cancer cells are all too often left behind, significantly increasing the chance of cancer returning across disease sites. Consequently, the surgeon is faced with a difficult clinical decision: remove an additional margin of healthy appearing tissue, risking additional morbidity or risk leaving microscopic disease behind. Microscopic residual disease (“MRD”) leads to increased local recurrence (“LR”) and, potentially, reduced overall survival (“OS”). Therefore patients are often subjected to additional treatment (such as re-resection, radiation, and/or chemotherapy) to reduce the chance of recurrence; a result that could have been avoided if the entire tumor was initially removed. Although crude methods exist to evaluate tumor in the operating room, definitive identification of MRD can only be determined days later after molecular staining and microscopic visualization of the excised specimen in a pathology laboratory, rendering it ineffective for intraoperative guidance. Similarly microscopic lymph node involvement (mLNI) often goes undetected, and detecting mLNI intraoperatively is of significant importance. Therefore this imager covers both imaging on the tissue surface and several (1-10) millimeters below the surface.
Identification of MRD is a prime concern in almost every oncological case. The device presented here is meant to be a platform imager for use with any disease subsite where surgical resection is necessary for cure, and for which there is a targeted agent capable of labeling and identifying the cancer cell. One example is breast cancer, whereby microscopic tumor is left in the tumor bed in one out of four operations. Microscopic residual disease doubles the rate of recurrence and thereby decreases overall survival. Therefore a repeat operation is essential. This could have avoided if all disease was resected during the initial operation. Another example is in prostate cancer, where a positive margin (another term for microscopic residual disease) increases the chance of cancer recurrence. Due to the morbidity of reoperation, patients with MRD are often advised to receive post-operative radiotherapy, lasting approximately 6 weeks with significant cost and additional side effects. Therefore, there is a need to intraoperatively identify MRD within the tumor bed to guide complete resection in a single surgery preventing both the morbidity and cost associated with multiple therapeutic procedures.
To maintain excellent oncologic outcomes across cancer types, while reducing the need for additional post-operative therapy, intraoperative assessment of MRD and mLNI in real-time with precise localization is critically needed. Thus, there is a need in the art for improved intra-operative resection devices, systems and methods.